Newborn Heart Rate as a Catalyst for Improved Survival

American Academy of Pediatrics

Status: Completed

Conditions: Neonatal Respiratory Depression; Stillbirth; Neonatal Bradycardia; Neonatal Resuscitation

Treatments: Other: Epoch 2: HBB with NeoBeat; Other: Epoch 3: HR-guided HBB

Study type: Observational

Funder types: Other

Identifiers

NCT03799861

7200AA18FA00010

Details and patient eligibility

About

Heart rate (HR) is not routinely assessed during newborn resuscitations in low- and lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh stillbirths have a heartbeat and are live born. The effect of a low-cost monitor for measuring HR on the problem of misclassification of stillbirths in LMICs is unknown.

Knowledge of HR during newborn resuscitation might also result in timely administration of appropriate interventions, and improvement in outcomes. Helping Babies Breathe (HBB), a resuscitation algorithm developed by the American Academy of Pediatrics (AAP), is widely accepted as the standard of care for newborn resuscitation in low-resource settings. In keeping with the International Liaison Committee on Resuscitation (ILCOR) recommendations that HR be measured during newborn resuscitation, HBB calls for HR assessment after 1 minute of positive-pressure ventilation with good chest movement (or sooner if there is a helper who can palpate/auscultate heart rate). However, given the frequent reality of a single provider attending deliveries in LMICs, as well as the currently available methods for assessing HR (i.e. palpitation or auscultation), assessment of HR is challenging to perform without delaying or stopping the provision of other life-saving interventions such as bag and mask ventilation. The effect of low-cost, continuous HR monitoring to guide resuscitation in these settings is unknown.

NeoBeat is a low-cost, battery-operated device designed by Laerdal Global Health for the measurement of newborn HR. The device can be placed rapidly on a newborn by a single provider, and within 5 seconds, displays HR digitally. A preliminary trial of NeoBeat in 349 non-breathing newborns in Tanzania detected a HR in 67% of newborns classified as stillbirths, suggesting up to two thirds of fresh stillbirths may be misclassified in similar settings.

This trial will evaluate: 1) the effectiveness of HBB in combination with NeoBeat for vital status detection on reduction of reported stillbirths, and 2) the effectiveness of HR-guided HBB on effective breathing at 3 minutes.

The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat will decrease the reported total stillbirth rate by 15% compared to standard care. The secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of newborns not breathing well at birth who are effectively breathing at 3 minutes by 50% compared to HBB with NeoBeat.

Enrollment: 24,034 patients

Sex: All

Ages: 28 to 45 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: all newborns delivered via vaginal, assisted or operative delivery at any of 3 participating maternity units in Kinshasa, Democratic Republic of Congo (DRC), during the study period will be enrolled. All newborns will be included, regardless of:

• intrauterine fetal demise
• birth weight
• congenital anomalies
• multiple gestation
• any maternal complication

Exclusion Criteria:

• Newborns transferred to the maternity unit following delivery at a referral hospital or in the community
• Miscarriages, or previable newborns, defined as gestational age <28 weeks (or if gestational age is unavailable, birth weight <1,000g) at the time of delivery

Trial design

24,034 participants in 3 patient groups

Epoch 1: Care prior to HBB training

Description:

A period of demographic and birth outcome data collection for a retrospective cohort of all infants born in the three study hospitals during the 18 months prior to the start of Epoch 2, reflecting care prior to HBB training.

Epoch 2: HBB with NeoBeat

Description:

Implementation of Helping Babies Breathe training in combination with NeoBeat for detection of HR in non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for prospective cohort of all infants born in the three study hospitals for a 9-month period.

Treatment:

Other: Epoch 2: HBB with NeoBeat

Epoch 3: HR-guided HBB

Description:

Implementation of HR-guided Helping Babies Breathe training with NeoBeat for measurement of HR throughout resuscitation of non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for a prospective cohort of all infants born in the three study hospitals for a 9-month period.

Treatment:

Other: Epoch 3: HR-guided HBB